Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Ankle Fractures
• Interventions: Procedure: Subcuticular Suture; Procedure: Simple Interrupted Suture

• Registration Number: NCT06496698
• Lead Sponsor: University of Puerto Rico

Brief Summary

Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.

Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Study Start: 2024-07-15
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.

Exclusion Criteria

• Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcuticular Suture Group	Subcuticular Suture	Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group.
Simple Interrupted Suture Group	Simple Interrupted Suture	Simple interrupted Monocryl 3-0 sutures will be placed on patients in the control group.

Primary Outcome Measures

Name	Time	Method
Postoperative Complication rates	2 and 8 weeks post-op.	Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery.

Secondary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale (POSAS)	2 and 8 weeks post-op.	The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive tool used to evaluate the quality of scars from both the patient's and observer's perspectives. It consists of two parts: the Patient Scale and the Observer Scale.
Self-reported foot and ankle score (SEFAS)	2 and 8 weeks post-op.	Consists of 12 items related to pain, limping, swelling, and use of orthotics and walking.